The European Commission published the proposed new European medical device regulations on September 26, 2012. At that time, it was expected by experts that the final wording of the regulation could be published in early 2014, prior to the European Parliament elections, coming into full effect three years later in 2017.
However, in October 2013, the European Parliament adopted a lot of amendments to the initial EC regulations such as the creation of an Assessment Committee for Medical Devices (ACMD) in order to provide the case-by-case assessment where its members deemed it necessary to ask for the review of the clinical data.
In this spring of this new year 2015, we are still waiting for the European Council to come out with a new Regulation proposal which may include some of the amendments made by the previous EU Parliament, maybe by June 2015.
But there is then an important step: the 3 bodies - the European Commission, the European Parliament and the European Council will have to agree on a final text !
Optimistic experts think that this should result in an adoption of the new regulation at the end of 2015.
Wait and See !
Written by René Clément on March 23, 2015
